Development of an Application for the Monitoring and Evaluation of Raynaud's Phenomenon

Application for Monitoring and Evaluation of Raynaud's Phenomenon

Sponsors

Lead sponsor: University Hospital, Grenoble

Source University Hospital, Grenoble
Brief Summary

To evaluate the feasibility of using a smartphone application for monitoring and evaluation of Raynaud's Phenomenon.

Overall Status Not yet recruiting
Start Date May 2020
Completion Date August 31, 2020
Primary Completion Date August 2, 2020
Study Type Observational
Primary Outcome
Measure Time Frame
Satisfaction assessed by a 5-points Likert scales about using the application for the monitoring and evaluation of Raynaud's Phenomenon 2 weeks
Secondary Outcome
Measure Time Frame
Relationship between cutaneous digital temperature assessed by thermography and the severity of Raynaud's Phenomenon 2 weeks
Relationship between cutaneous digital temperature assessed by thermography and the frequency of RP attacks 2 weeks
Relationship between cutaneous digital temperature assessed by thermography and the duration of RP attacks 2 weeks
Relationship between cutaneous digital temperature assessed by thermography and pain during RP attacks 2 weeks
Effect of Raynaud etiology on thermographic data 2 weeks
Effect of Raynaud treatment on thermographic data 2 weeks
Enrollment 120
Condition
Intervention

Intervention type: Other

Intervention name: Smartphone application

Description: use of smartphone application during 2 weeks to 3 months to collect frequency and duration of crises, RCS, photography of finger.

Arm group label: Raynaud phenomenon

Eligibility

Sampling method: Non-Probability Sample

Criteria:

Inclusion Criteria:

- primary or secondary Raynaud phenomenon clinically diagnosed by a physician

- Phone compatible with the application (most Android smartphones)

- Non-opposition of participation in the study

- Affiliation to the social security scheme or beneficiary of such a scheme

Exclusion Criteria:

- Subject under administrative or judicial supervision

- Subject not speaking and not understanding French

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Matthieu Roustit, PharmD, PhD Principal Investigator University Hospital, Grenoble
Overall Contact

Last name: Matthieu Roustit, PharmD, PhD

Phone: +33476767856

Email: [email protected]

Verification Date

March 2020

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Arm group label: Raynaud phenomenon

Description: Use of smartphone application

Acronym RaynaudMoni
Patient Data No
Study Design Info

Observational model: Case-Only

Time perspective: Prospective

Source: ClinicalTrials.gov